Notified body · Verified from EUDAMED
We show only what EUDAMED publishes. EUDAMED is still being populated — the absence of a certificate here does not mean none exists. Every figure links back to the official record so you can verify it yourself.
Lens 03 · Certificates
What it means: most of this body's certificates are live; a small share have ended or had adverse action.
| Status | Count | Distribution | Share |
|---|---|---|---|
| Issued | 11 | 78.6% | |
| Supplemented | 1 | 7.1% | |
| Amended | 1 | 7.1% | |
| Reissued | 1 | 7.1% | |
| Total recorded | 14 | 100% |
+ 1 expired (derived from the expiry date, not a EUDAMED status).
New certificates per year — the curve of EUDAMED adoption.
Lens 04 · What it certifies
What it means: higher classes (MDR III, IVDR D) carry the strictest scrutiny — a window into how high-stakes this body's work runs.
| Framework | Class | Certs | Distribution |
|---|---|---|---|
| MDR | Class III | 14 |
A certificate may cover several risk classes; these counts are not additive.
Common questions
Based on EUDAMED data, DEKRA Certification GmbH (NB 0124) has issued 14 certificates: 14 under the EU MDR and 0 under the EU IVDR. EUDAMED is still being populated, so this is a lower bound, not a complete history.
Across its issued certificates it has covered MDR Class I, IIa, IIb and III devices and IVDR Class A, B, C and D devices, including the highest-risk MDR Class III and IVDR Class D.
Yes. This body is designated under the EU IVDR (2017/746) and the EU MDR (2017/745), plus the legacy AIMDD, MDD and IVDD directives. Its official scope of designation is published on NANDO ↗.
In one line
DEKRA Certification GmbH (notified body 0124) is a Germany notified body designated under the EU MDR and IVDR. Based on EUDAMED data, it has issued 14 certificates (14 MDR, 0 IVDR) to 5 manufacturers across 3 countries.
Lens 05 · Who relies on it
What it means: 5 distinct manufacturers across 3 countries rely on this body.
| Manufacturer | Country | Certs |
|---|---|---|
| Occlutech GmbH | 🇩🇪 DE | 4 |
| NVT GmbH | 🇩🇪 DE | 4 |
| Joline GmbH & Co. KG | 🇩🇪 DE | 2 |
| Occlutech Tıbbi Ürünler San. ve Tic. Ltd. Şti | 🇹🇷 TR | 2 |
| Artivion, Inc. | 🇺🇸 US | 2 |
| Country | Manufacturers | Share |
|---|---|---|
| 🇩🇪 Germany | 3 | |
| 🇹🇷 Türkiye | 1 | |
| 🇺🇸 United States | 1 | |
| across 5 manufacturers | 5 | 3 countries total |
Lens 01 · Mandate
The regulations this body is designated under, plus any predecessor directives.
| Regulation | Designation | Authoritative record |
|---|---|---|
| IVDR | Active | Verify on NANDO ↗ |
| MDR | Active | Verify on NANDO ↗ |
| MDD(legacy) | Designated (legacy) | — |
“Active” means the designation is currently valid in NANDO, the EU’s official register; where NANDO does not confirm an active status we show “Designated” and link out rather than a status we cannot verify. Active status verified on NANDO Jun 29, 2026. Official scope of designation is published on NANDO →